Bioequivalency Study of CM082 Tablet in Healthy Volunteers

NCT04328506 | Completed Phase 1

• 1 other identifier: CM082-CA-I-108
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this study is to evaluate the bioequivalency of two preparations of CM082 tablet in Chinese healthy volunteers.

Conditions

Advanced Malignant Solid Tumors

Outcome Measures

Primary Outcomes (3)

• Peak plasma concentration(Cmax) of CM082 (test product or reference product) under fasted state or after meal

  The Cmax ofCM082 (test product or reference product) in under fasted state or after meal blood samples of each subject over a 72 hour period post dose

  pre-dose(30minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,7,8,10,12,16,24,36,48,72 hour]

• Area under the plasma concentration versus time curve(AUC) of CM082 (test product or reference product) under fasted state or after meal

  The AUC of CM082 (test product or reference product) in under fasted state or after meal blood samples of each subject over a 72 hour period post dose

  pre-dose(30minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,7,8,10,12,16,24,36,48,72 hour]

• Time of maximum concentration (Tmax) of CM082 (test product or reference product) under fasted state or after meal

  The Tmax of CM082 (test product or reference product) in under fasted state or after meal blood samples of each subject over a 72 hour period post dose

  pre-dose(30minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,7,8,10,12,16,24,36,48,72 hour]

Secondary Outcomes (1)

• Percentage of adverse events

  From the first occurrence of adverse events after administration to the cessation of adverse events, assessed up to 2 months

Study Arms (4)

T-R cohort under fasted state

EXPERIMENTAL

Subjects will be administered with one single dose of CM082 tablet (test product) under fasted state, after a wash period of 5 days, the subjects will be administered with one single dose of CM082 tablet (reference product) under fasted state.

Drug: CM082 tablet (test product); Drug: CM082 tablet (reference product)

R-T cohort under fasted state

EXPERIMENTAL

Subjects will be administered with one single dose of CM082 tablet (reference product) under fasted state, after a wash period of 5 days,the subjects will be administered with one single dose of CM082 tablet (test product) under fasted state.

Drug: CM082 tablet (test product); Drug: CM082 tablet (reference product)

T-R cohort after meal

EXPERIMENTAL

Subjects will be administered with one single dose of CM082 tablet (test product) after meal, after a wash period of 5 days,the subjects will be administered with one single dose of CM082 tablet (reference product) after meal.

Drug: CM082 tablet (test product); Drug: CM082 tablet (reference product)

R-T cohort after meal

EXPERIMENTAL

Subjects will be administered with one single dose of CM082 tablet (reference product) after meal, after a wash period of 14 days,the subjects will be administered with one single dose of CM082 tablet (test product) after meal

Drug: CM082 tablet (test product); Drug: CM082 tablet (reference product)

Interventions

CM082 tablet (test product) DRUG

Test product(T)：100mg CM082 tablet manufactured by Betta Pharmaceuticals

R-T cohort after meal; R-T cohort under fasted state; T-R cohort after meal; T-R cohort under fasted state

CM082 tablet (reference product) DRUG

Reference product(R)：100mg CM082 tablet manufactured by Catalent Pharma Solutions

R-T cohort after meal; R-T cohort under fasted state; T-R cohort after meal; T-R cohort under fasted state

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male body weight≥50.0kg or female body weight≥45.0kg; BMI between 19.0-26.0 kg/m2(inclusive)
• Generally in good health, with no history of chronic disease or sever disease
• No (clinical significant) abnormal findings in clinical laboratory tests and physical examinations
• No plan for pregnancy in coming 6 months, and must practice effective contraception; No plan for sperm or egg donation
• Written informed consent

You may not qualify if:

• History of food or drug allergies
• Clinical significant disease or disorders
• Received surgery in 3 months before screening, or have plan for surgery during the study
• Participated in other clinical trials within 3 months before screening
• Intolerant of venipuncture, history of fainting needle and blood
• Lactose intolerant
• Drug abusing in 3 months
• Donated ≥200 mL of blood within 3 months before screening
• Pregnant or under lactation period (female subjects)
• Received any prescription drug, over-the-counter drug, prescription drug and Chinese herbal drug in 2 weeks, with the exception of vitamins and acetaminophen
• Received any vaccine in 4 weeks
• Excessively smoking, alcohol or coffin-containing beverage drinking in 3 months
• Other circumstances that is deemed not appropriate for the study

Sponsors & Collaborators

• AnewPharma: lead

Study Sites (1)

The 1st Phase Clinical Research Center of the Second Affiliated Hospital of Zhejiang University Medical College

Hangzhou, Zhejiang, 311009, China

Location

MeSH Terms

Interventions

vorolanib

Study Officials

• zourong ruan

  the Second Affiliated Hospital of Zhejiang University Medical College

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: March 31, 2020
• Study Start: June 1, 2020
• Primary Completion: July 27, 2020
• Study Completion: July 27, 2020
• Last Updated: November 26, 2021

Record last verified: 2020-03

Locations

CN (1)